CN106456010B

CN106456010B - Baroreceptor mapping system

Info

Publication number: CN106456010B
Application number: CN201580033102.6A
Authority: CN
Inventors: 安德鲁·L·第·考克; 埃里克·A·莫科尔科; 布莱恩·索尔蒂斯; 道格·E·吉沃扬; 詹姆斯·E·布拉德; 杰克·戈登
Original assignee: Cardiac Pacemakers Inc
Current assignee: Cardiac Pacemakers Inc
Priority date: 2014-06-19
Filing date: 2015-06-18
Publication date: 2020-03-13
Anticipated expiration: 2035-06-18
Also published as: AU2015277004B2; JP6306742B2; AU2015277004A1; EP3157618A1; WO2015195982A2; CN106456010A; EP3157618B1; AU2015277002B2; JP6306211B2; AU2015277002A1; JP2017521108A; CN106659386A; EP3157617A2; US9763582B2; WO2015195982A3; CN106659386B; US20150366465A1; WO2015195980A1; JP2017518096A; EP3157617B1

Abstract

A system includes a mapping device, a stimulator, and a marker. The mapping device includes a plurality of electrodes to be placed on a baroreceptor region of a patient to map baroreceptors in the baroreceptor region. The stimulator is to stimulate a selected electrode of the plurality of electrodes to obtain a physiological response from the patient in response to stimulation by the selected electrode. A marker is to be attached to the patient to mark a position of at least one of the selected electrodes based on an analysis of a physiological response from the patient, wherein the marker is to maintain its position on the patient when the mapping device is removed from the patient.

Description

Baroreceptor mapping system

Cross Reference to Related Applications

This application claims priority to provisional application No.62/014,390 filed on date 6/19 2014 and provisional application No.62/014,496 filed on date 6/19 2014, both of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure relates generally to medical devices and, more particularly, to systems, devices, and methods for delivering electrical stimulation.

Background

Neurostimulation has been proposed as a therapy to treat excessive stress (also known as hypertension). It has been proposed that electrical stimulation directed to the baroreceptor region can be used to induce a baroreceptor reflex (baroreceptor reflex) that lowers blood pressure. Through the negative feedback loop of the baroreflex, the central nervous system regulates blood pressure to maintain it at a relatively steady level. For example, hypertension, which causes the arteries to stretch, activates baroreceptors to send nerve impulses to the brain, and in response, the brain controls the pumping activity of the heart and vasodilation to lower blood pressure.

The change in blood pressure due to electrical stimulation of a location in the baroreceptor region fluctuates dramatically based on the location of the location in the baroreceptor region, i.e., the change in blood pressure due to stimulation at a first location in the baroreceptor region can be significantly different from the change in blood pressure due to stimulation at a second location in the baroreceptor region. Animal experiments indicate that stimulation sites separated by less than 1 millimeter (mm) can produce dramatically different changes in blood pressure. Thus, implantation of a stimulation device on the baroreceptor region typically requires extensive mapping of the region to find a location that provides effective or most effective control of blood pressure.

Typically, the surgeon manually holds one or more electrodes at various locations on the baroreceptor region to map the region during the implantation procedure. Mapping the baroreceptor region takes a lot of time and effort due to the difficulty of manually positioning the electrodes at a site, stimulating the baroreceptor region at the site, waiting for a change in blood pressure, measuring the change in blood pressure, and returning the blood pressure to a stable level before positioning the electrodes at the next site and repeating the process. Longer surgical times increase the risk to the patient and lead to physician fatigue and dissatisfaction. In addition, this manual procedure may introduce mechanical activation of the baroreceptors, which hampers the assessment of the changes in blood pressure due to electrical stimulation. As a result, a complete mapping of the baroreceptor region is often not available, which can result in suboptimal implant locations, suboptimal stimulation therapy, and loss of therapeutic value over time.

Disclosure of Invention

Example 1 is a system comprising a mapping device, a stimulator, and a marker. The mapping device includes a plurality of electrodes to be placed on a baroreceptor region of a patient to map baroreceptors in the baroreceptor region. The stimulator is to stimulate a selected electrode of the plurality of electrodes to obtain a physiological response from the patient in response to stimulation by the selected electrode. A marker is to be attached to the patient to mark the location of at least one of the selected electrodes based on an analysis of a physiological response from the patient. The marker is to be used to maintain its position on the patient when the mapping device is removed from the patient.

In example 2, the system according to example 1 includes an implantable device including at least one implantable electrode to be aligned on the baroreceptor region using the marker.

In example 3, the system of any of examples 1 and 2, wherein the mapping device includes at least one marker aperture extending through the mapping device, and the marker is to be attached to the patient through the at least one marker aperture.

In example 4, the system of any of examples 1-3, wherein at least one of the plurality of electrodes has a closed curve mapping electrode shape including a marker aperture extending through an interior region of the closed curve mapping electrode shape.

In example 5, the system of any of examples 1-4, wherein the implantable device includes at least one alignment aperture extending through the implantable device, and the implantable device is to be aligned on the baroreceptor region via the marker and the at least one alignment aperture.

In example 6, the system of any of examples 1-5, wherein the implantable device includes an implantable electrode having a closed curve implantable electrode shape and an alignment aperture extending through an interior region of the closed curve implantable electrode shape to be aligned on the baroreceptor region via the marker and the alignment aperture.

In example 7, the system of any of examples 1-6, wherein the marker includes at least one of a staple shape, a hook, and a suture for attaching the marker to the patient, and a stop for adjusting an insertion distance of the marker in the patient.

In example 8, the system of any of examples 1-7, wherein the mapping device includes a self-winding sheet that secures the mapping device to the patient.

In example 9, the system of any of examples 1-8, comprising a sensor to sense a physiological response and provide a signal indicative of the physiological response from the patient, wherein the stimulator receives the signal and analyzes the signal to determine a location of at least one of the selected electrodes to be labeled with the marker.

Example 10 is a system for mapping and labeling baroreceptors in a baroreceptor region of a patient. The system includes a mapping device, a sensor, a controller, and a marker. The mapping device includes a plurality of electrodes to be placed on a baroreceptor region of a patient. The sensor is to sense a physiological parameter and provide a signal indicative of the physiological parameter. The controller is to receive the signal from the sensor and analyze the signal to obtain a physiological response to stimulation of an electrode of the plurality of electrodes. Furthermore, the controller is to be used for storing data about the stimulated electrodes and the corresponding physiological responses in a map of the baroreceptor region. A marker is to be attached to the patient to mark a location of at least one of the electrodes that, when stimulated, provides an effective physiological response based on analysis of the map of the baroreceptor region.

In example 11, the system of example 10, wherein the controller analyzes the map of baroreceptor regions to identify a location of at least one of the electrodes.

In example 12, the system of any of examples 10 and 11, wherein the marker is to remain attached to the patient when the mapping device is removed from the baroreceptor region of the patient.

In example 13, the system according to examples 10-12 includes an implantable device including at least one implantable electrode to be aligned on the baroreceptor region using the marker.

Example 14 is a method for manufacturing a self-winding mapping device. The method comprises the following steps: unwinding and stapling the self-wrapping sheet to a flat surface; applying a layer of adhesive to at least part of the inward wound portion of the self-wrapping sheet; laminating the mapping device to the self-wrapping sheet via an adhesive to provide a laminated assembly; winding the laminate assembly around a mandrel to allow the adhesive to be processed in a wound state; and unwinding the winding from the winding map device.

In example 15, the method of example 14, wherein the self-wrapping sheet comprises a self-wrapping silicone sheet and the layer of adhesive comprises a layer of silicone adhesive.

Example 16 is a system comprising a mapping device, a stimulator, and a marker. The mapping device includes a plurality of electrodes to be placed on a baroreceptor region of a patient. The stimulator is to stimulate a selected electrode of the plurality of electrodes to obtain a physiological response from the patient in response to stimulation by the selected electrode. The marker is to be attached to the patient and marks a location of at least one of the selected electrodes based on an analysis of a physiological response from the patient.

In example 17, the system of example 16 includes an implantable device including at least one implantable electrode to be aligned on the baroreceptor region via a marker and sutured into place on the baroreceptor region.

In example 18, the system of any of examples 16 and 17, wherein the mapping device comprises at least one marking aperture extending through the mapping device and the implantable device comprises at least one alignment aperture extending through the implantable device, wherein the marker is to be attached to the patient through the at least one marking aperture and the implantable device is to be aligned on the baroreceptor region via the at least one alignment aperture and the marker.

In example 19, the system of any of examples 16-18, wherein the mapping device includes at least one aperture extending therethrough, and the marker is to be attached to the patient through the at least one aperture.

In example 20, the system of any of examples 16-19, wherein the mapping device includes at least one aperture extending through the mapping device and adjacent to at least one of the plurality of electrodes.

In example 21, the system of any of examples 16-20, wherein at least one of the plurality of electrodes has a closed curve electrode shape, and the mapping device has at least one aperture extending through the mapping device and through an interior region of the closed curve electrode shape.

In example 22, the system of any of examples 16-21, wherein the marker includes at least one of a peg shape, a wire, a hook, and a stop device to adjust an insertion distance of the marker in the patient for attaching the marker to the patient, and the marker is to be attached to the patient through a through hole aperture in the mapping device.

In example 23, the system of any of examples 16-22, wherein the mapping device comprises a self-wound sheet that secures the mapping device to the patient.

In example 24, the system of any of examples 16-23, comprising a sensor to sense a physiological response and provide a signal indicative of the physiological response from the patient, wherein the stimulator receives the signal and analyzes the signal to determine a location of at least one of the selected electrodes to be labeled with the marker.

Example 25 is a method, comprising: maintaining a mapping device comprising a plurality of electrodes on a baroreceptor region of a patient; stimulating a selected electrode of the plurality of electrodes with a stimulator to obtain a physiological response from the patient in response to the stimulation of the selected electrode; marking a location of at least one of the selected electrodes on the baroreceptor region of the patient with a marker based on an analysis of a physiological response from the patient; removing the mapping device from the patient; and maintaining the marker at a location of at least one of the selected electrodes on the baroreceptor region of the patient.

In example 26, the method of example 25, wherein marking the location comprises attaching a marker to the patient through at least one marking aperture extending through the mapping device.

In example 27, the method according to any one of examples 25 and 26, wherein marking the location includes at least one of inserting a staple into the patient through at least one marking aperture extending through the mapping device and suturing a thread into the patient through the at least one marking aperture extending through the mapping device.

In example 28, the method of any of examples 25-27, comprising: aligning the implantable device with the marker on the baroreceptor region; and suturing the implantable device aligned with the marker on the baroreceptor region to the patient.

In example 29, the method of any of examples 25-28, comprising: the implantable device is aligned on the baroreceptor region via positioning a marker through at least one alignment aperture extending through the implantable device.

In example 30, the method of any of examples 25-29, wherein the marker is one of a staple and a suture, and the method comprises: the implantable device is aligned on the baroreceptor region via positioning a marker through at least one alignment aperture extending through the implantable device.

In example 31, the method of any of examples 25-30, wherein maintaining the mapping device comprises wrapping the self-wrapping mapping device around at least one body part of the patient.

In example 32, the method of any of examples 25-31, comprising: sensing a physiological response from the patient with a sensor; providing a signal indicative of a physiological response from the patient; receiving a signal at a stimulator; and analyzing the signal with a stimulator to determine a location of at least one of the selected electrodes on the baroreceptor region of the patient to be labeled with the marker.

Example 33 is a method for manufacturing a self-winding mapping device. The method comprises the following steps: unwinding and stapling the self-wrapping sheet to a flat surface; applying a layer of adhesive to at least part of the inward wound portion of the self-wrapping sheet; laminating the mapping device to the self-wrapping sheet via an adhesive to provide a laminated assembly; winding the laminate assembly around a mandrel to allow the adhesive to be processed in a wound state; and unwinding the winding from the winding map device.

In example 34, the method of example 33, wherein the self-wrapping sheet comprises a self-wrapping silicone sheet.

In example 35, the method of any one of examples 33 and 34, wherein the layer of adhesive comprises a layer of silicone adhesive.

While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

Drawings

Fig. 1 is a schematic diagram illustrating a system for mapping and labeling baroreceptors in a baroreceptor region of a patient according to some embodiments described in the present disclosure.

Fig. 2 is a schematic diagram illustrating a mapping device and marker placed on an artery according to some embodiments described in this disclosure.

Fig. 3 is a schematic diagram illustrating a mapping apparatus including a mapping electrode region and a peripheral region according to some embodiments described in the present disclosure.

Fig. 4 is a schematic diagram illustrating a mapping device and a tag according to some embodiments described in the present disclosure, where the mapping device includes a through-hole aperture through a mapping electrode.

Fig. 5 is a schematic diagram illustrating a mapping device and markers according to some embodiments described in the present disclosure, where the mapping device includes a through-hole aperture proximate to a mapping electrode.

Fig. 6A is a schematic diagram illustrating a marker having a straight nail shape according to some embodiments described in the present disclosure.

Fig. 6B is a schematic diagram illustrating a marker having a straight nail shape and including an insertion stop device according to some embodiments described in the present disclosure.

Fig. 6C is a schematic diagram illustrating a marker having a hook at one end of the marker according to some embodiments described in the present disclosure.

Fig. 6D is a schematic diagram illustrating a marker having a hook at one end of the marker and including an insertion stop device according to some embodiments described in the present disclosure.

Fig. 6E is a schematic diagram illustrating a marker having a helical structure at one end of the marker according to some embodiments described in the present disclosure.

Fig. 6F is a schematic diagram illustrating a marker having a helical structure at one end of the marker and including an insertion stop device according to some embodiments described in the present disclosure.

Fig. 7A is a schematic diagram illustrating a spike-shaped marker attached to an artery after a mapping device has been removed from the artery, according to some embodiments described in the present disclosure.

Fig. 7B is a schematic diagram illustrating a line marker attached to an artery after a mapping device has been removed from the artery, according to some embodiments described in the present disclosure.

Fig. 8 is a schematic diagram illustrating an implantable device and a marker attached to an artery according to some embodiments described in the present disclosure.

Fig. 9 is a schematic diagram illustrating an implantable device including an implantable electrode region and a peripheral region according to some embodiments described in the present disclosure.

Fig. 10 is a schematic diagram illustrating an implantable device and marker according to some embodiments described in the present disclosure, wherein the implantable device includes a through-hole aperture through an implantable electrode.

Fig. 11 is a schematic diagram illustrating an implantable device and marker according to some embodiments described in the present disclosure, wherein the implantable device includes a through-hole aperture proximate to an implantable electrode.

Fig. 12 is a schematic diagram illustrating an example of an implantable system according to some embodiments described in the present disclosure.

Fig. 13 is a flow chart illustrating a method of mapping a baroreceptor region, marking an identified effective location in the baroreceptor region, and attaching an implantable device at the identified effective location on the baroreceptor region, according to some embodiments described in the present disclosure.

Fig. 14 is a schematic diagram illustrating a mapping device prior to attaching a self-wrapping silicone sheet according to some embodiments described in this disclosure.

Fig. 15 is a schematic diagram illustrating a self-wrapping silicone sheet according to some embodiments described in the present disclosure.

Fig. 16 is a schematic diagram illustrating a mapping device attached to a self-wrapping silicone sheet by a silicone adhesive, according to some embodiments described in the present disclosure.

Fig. 17 is a schematic diagram illustrating a flattened self-winding mapping device that cuts off excess of self-winding silicone sheet, according to some embodiments described in this disclosure.

Fig. 18 is a schematic diagram illustrating a wound self-winding mapping device, according to some embodiments described in this disclosure.

Fig. 19 is a flow chart illustrating a method of generating a self-wrapping map device according to some embodiments described in this disclosure.

Fig. 20 is a schematic diagram illustrating a mapping apparatus for mapping a targeted baroreceptor region, in accordance with some embodiments.

Fig. 21 is a schematic diagram illustrating selection of zone 1 and division of zones 1 through 3 and 4 according to some embodiments described in this disclosure.

Fig. 22 is a schematic diagram illustrating selection of zone 4 and division of zone 4 into zones 5 and 6 according to some embodiments described in this disclosure.

Fig. 23 is a schematic diagram illustrating selection of zone 6 and division of zone 6 into zones 7 and 8 according to some embodiments described in this disclosure.

Fig. 24 is a schematic diagram illustrating selection of zone 7 and division of zone 7 into

zones

9 and 10 according to some embodiments described in this disclosure.

Fig. 25 is a schematic diagram showing all of regions 1-10 and indicating selected regions with different cross-hatching for the refinement processes of fig. 20-24, according to some embodiments described in the present disclosure.

Fig. 26A is a flow chart illustrating a first portion of a mapping algorithm for mapping a baroreceptor region according to some embodiments described in the present disclosure.

Fig. 26B is a flow diagram illustrating a second portion of a mapping algorithm for mapping a baroreceptor region according to some embodiments described in the present disclosure.

Fig. 26C is a flow diagram illustrating a third portion of a mapping algorithm for mapping a baroreceptor region according to some embodiments described in the present disclosure.

While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, it is not intended to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

Detailed Description

Disclosed herein is a system, apparatus and method for: mapping the baroreceptor region using a mapping device; marking a location on the baroreceptor region based on the mapping result; and positioning the implantable device at a location on the baroreceptor region after removing the mapping device from the baroreceptor region.

The Autonomic Nervous System (ANS) regulates unconscious organs such as the respiratory, digestive, blood vessels, and heart. The ANS may function in an involuntary, reflex manner to regulate glands and muscles in the skin, the eye, the stomach, the intestine and the bladder, and to regulate the myocardium and muscles around blood vessels. The ANS includes the sympathetic nervous system and the parasympathetic nervous system. The sympathetic nervous system is associated with stress and "either warfare or escape response". Among other effects, the "or fight or escape response" increases blood pressure and heart rate to increase blood flow in skeletal muscles, and it reduces digestion to provide energy for fight or escape. The parasympathetic nervous system is involved in relaxation and in "rest and digestive reactions", and in addition to this effect, it also reduces blood pressure and heart rate, and increases digestion. When the sympathetic nervous system is stimulated, heart rate and pressure increase, and when the sympathetic nervous system is inhibited and the parasympathetic nervous system is stimulated, heart rate and pressure decrease.

The baroreceptor zone (also referred to as a baroreceptor zone) senses changes in pressure, such as changes in blood pressure. The baroreceptors in the baroreceptor region are sensitive to stretching of the vessel wall due to the increase in blood pressure. Baroreceptors act as receptors for a central reflex mechanism called baroreflex. Activated baroreceptors trigger baroreflex that acts as a negative feedback loop that reduces blood pressure. In operative pressure reflection, the increase in blood pressure stretches the blood vessel, which in turn activates the baroreceptors in the vessel wall. Activation of baroreceptors inhibits the sympathetic nervous system and excites the parasympathetic nervous system, which reduces peripheral vascular resistance and reduces heart rate and contractility to reduce blood pressure.

Baroreceptors can be electrically stimulated to induce a baroreflex, where as used herein, electrical stimulation of a baroreceptor includes stimulation of neural tissue including nerve endings that innervate the baroreceptor. Stimulation of neural tissue in the vicinity of baroreceptors results in neural signals being sent to the central nervous system and a baroreflex being induced. Electrical stimulation of baroreceptors that induce baroreflex has been proposed for a variety of treatments, including over-tension treatment, heart failure treatment, and arrhythmia treatment. The electrical stimulation of the baroreceptors may be unipolar stimulation or bipolar stimulation. However, modeling indicates that the tissue directly below the cathode receives the greatest amount of energy, so that the cathode can be located in the baroreceptor region for mapping the location of the baroreceptor region and the anode, which appears to be less important, can be located away from the baroreceptor region.

Baroreceptors are located throughout the body, including in the arch of the aorta and the carotid sinuses of the left and right internal carotid arteries. Baroreceptor distribution can vary from person to person. However, baroreceptors appear to be more concentrated near the bifurcation of the Internal Carotid Artery (ICA) and the External Carotid Artery (ECA), which are separate from the Common Carotid Artery (CCA).

Fig. 1 is a schematic diagram illustrating a system 20 for mapping and labeling baroreceptors in a baroreceptor region of a patient according to some embodiments described in the present disclosure. System 20 includes a mapping device 22, a stimulator 24, and a marker 26. System 20 may be used to map and mark baroreceptors in baroreceptor regions, such as the carotid sinus of ICA, the carotid sinus of ECA, the area near the bifurcation of ICA and ECA, the arch of the aorta, and others.

The mapping means 22 comprise a plurality of mapping electrodes 28 to be placed on the baroreceptor region. The mapping electrodes 28 are used to deliver electrical stimulation to the baroreceptor region. The mapping device 22 is shaped to be secured to the baroreceptor region and to hold the mapping electrode 28 on the baroreceptor region. In fig. 1, the mapping device 22 is rectangular in shape and is placed over the artery 30. In some embodiments, the mapping device 22 is configured to wrap completely around the artery 30 and hold the mapping electrodes 28 in place on the baroreceptor region. In some embodiments, the mapping device 22 is configured to partially wrap around the artery 30 and hold the mapping electrodes 28 in place on the baroreceptor region. In some embodiments, the mapping device 22 is configured to be pressed against the artery 30 and hold the mapping electrodes 28 in place on the baroreceptor region. In some embodiments, the mapping device 22 is configured to hold the mapping electrodes 28 in place on the baroreceptor region, whether the baroreceptor region may be anywhere on the patient's body.

The mapping device 22, which includes a plurality of mapping electrodes 28, is electrically coupled to the stimulator 24 by a mapping device cable 32 and a reusable connector cable 34. In some embodiments, each of the mapping electrodes 28 is electrically coupled to a separate lead in the cable 32 and each of the separate leads is electrically coupled to the stimulator 24 by a reusable connector cable 34. In some embodiments, cable 32 is electrically coupled directly to stimulator 24.

Stimulator 24 selects one or more of mapping electrodes 28 and stimulates the selected mapping electrode(s) to obtain one or more physiological responses from the patient. In some embodiments, stimulator 24 may deliver unipolar or bipolar electrical stimulation to the tissue of the baroreceptor region through mapping electrodes 28. In some embodiments, the one or more physiological responses include a change in blood pressure of the patient. In some embodiments, the one or more physiological responses include a change in heart rate of the patient. In some embodiments, the one or more physiological responses include a change in tissue impedance of the patient.

The physiological response may be obtained manually from the patient, or at least optionally, in some embodiments, the physiological response may be obtained automatically from the patient using one or more sensors, such as sensor 36. The sensor 36 is in communication with or attached to the patient via a communication path 38 and is communicatively coupled to the stimulator 24. The sensor 36 senses at least one physiological parameter under consideration and provides a signal indicative of the sensed physiological parameter. The at least one physiological parameter under consideration may include a blood pressure of the patient, a heart rate of the patient, and a tissue impedance of the patient. In some embodiments, sensor 36 may comprise a direct pressure sensor. In some embodiments, the sensor 36 may include a heart rate sensor. In some embodiments, sensor 36 may comprise a tissue impedance sensor.

Stimulator 24 receives signals from sensors 36, analyzes the signals to obtain physiological responses, and stores data in a map of the baroreceptor region, indicating the stimulated electrode(s) and corresponding physiological responses. This process is repeated for at least some of the plurality of mapping electrodes 28 to map the baroreceptor region.

The mapping of the baroreceptor region is analyzed to obtain a location of at least one of the mapping electrodes 28 that provides an effective physiological response when stimulated, referred to herein as an identified effective location on the baroreceptor region. The effective physiological response may be a level of change that matches or exceeds a threshold level of change of one or more of the physiological parameters under consideration. In some embodiments, stimulator 24 analyzes the mapping of the baroreceptor region to obtain a location on the baroreceptor region that provides at least one of the valid physiological responses in mapping electrode 28.

In one example, stimulator 24 selects one of mapping electrodes 28 and, to stimulate the patient, stimulator 24 provides a current through the selected mapping electrode 28. The patient's blood pressure changes in response to the current through the selected mapping electrode 28, wherein the change in the patient's blood pressure begins after electrical stimulation has begun and is typically completed within 1 minute from the beginning of the electrical stimulation. In some embodiments, stimulator 24 provides a current through mapping electrode 28 of between 2 and 5 milliamps (mA) to stimulate the patient. In some embodiments, stimulator 24 provides a current through mapping electrode 28 of between 2.9mA and 4.1mA to stimulate the patient. In some embodiments, stimulator 24 provides current for a period of time less than 5 seconds. In some embodiments, the patient's blood pressure begins to change within 5 seconds of the beginning of the electrical stimulation, and the measurement of the change in blood pressure ends 1 minute or less after the stimulation has begun.

To further illustrate this example, the sensor 36 includes a pressure sensor that provides a signal indicative of the patient's blood pressure. The stimulator 24 receives the signal and analyzes the signal to obtain a change in the blood pressure of the patient. Stimulator 24 stores data in a map of the baroreceptor region, indicating the stimulated electrodes and corresponding changes in blood pressure. This process is repeated for at least one other electrode of the plurality of mapping electrodes 28 to map the baroreceptor region. The stimulator 24 analyzes the mapping of the baroreceptor region to select a location in the baroreceptor region that provides a maximum reduction in the patient's blood pressure within 1 minute, which in this example is an effective physiological response. To analyze the mapping and select the location, the stimulator 24 compares the magnitude of the change in blood pressure for the different electrode locations and selects the maximum change in blood pressure (which is a decrease in blood pressure) and the corresponding electrode location. In some embodiments, the reduction in blood pressure in response to a 3mA stimulation by one of the electrodes may be greater than 10 mmHg.

In some embodiments, stimulator 24 includes a stimulation controller 40, a stimulation pulse generator 42, and a switch 44. Controller 40 is communicatively coupled to pulse generator 42 via a communication path 46 and to switch 44 via a communication path 48. The pulse generator 42 is electrically coupled to the switch 44 via a conductive path 50, and the switch 44 is electrically coupled to the reusable connector cable 34, the cable 32, and the plurality of mapping electrodes 28 via a conductive path 52. In some embodiments, controller 40 is communicatively coupled to sensor 36 via

communication paths

38 and 54.

Controller 40 executes computer-executable instructions that cause stimulator 24 to provide the systems and methods described in this disclosure. In some embodiments, the controller 40 is at least one processor. In some embodiments, stimulator 24 includes a memory including one or more non-transitory computer-readable storage media having computer-executable instructions embodied thereon that, when executed by controller 40, cause stimulator 24 to provide the systems and methods described in this disclosure.

The controller 40 controls the switches 44 to selectively connect one or more of the mapping electrodes 28 to the pulse generator 42. In some embodiments, controller 40 controls switches 44 to connect one or more of mapping electrodes 28 as one or more cathodes to pulse generator 42. In some embodiments, controller 40 controls switches 44 to connect one or more of mapping electrodes 28 as one or more anodes to pulse generator 42.

The controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 28. In some embodiments, the pulse generator 42 may provide unipolar or bipolar electrical stimulation to the tissue of the baroreceptor region through the mapping electrodes 28. In some embodiments, the controller 40 controls the switches 44 to connect two or more of the mapping electrodes 28 to the pulse generator 42 for bipolar stimulation, i.e., at least one cathodic electrode and at least one anodic electrode. In some embodiments, the controller 40 controls the switches 44 to connect one or more of the mapping electrodes 28 to the pulse generator 42 for unipolar stimulation.

In some embodiments, the controller 40 receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated electrode(s) and corresponding physiological response. In some embodiments, the controller 40 analyzes the mapping of the baroreceptor region to obtain a location of at least one of the mapping electrodes 28 that provides a valid physiological response when stimulated, referred to herein as an identified valid location in the baroreceptor region.

The marker 26 is to be attached to the patient to mark a location in the baroreceptor region of at least one of the mapping electrodes 28 based on an analysis of a physiological response from the patient. The marker 26 can be attached to the patient after the mapping device 22 and stimulator 24 have mapped the baroreceptor region and the mapping has been analyzed to identify electrode locations that provide a valid physiological response when stimulated. A marker 26 is attached to the patient relative to the identified electrode position to indicate and keep track of the identified effective location on the baroreceptor region. The marker 26 maintains its position on the patient when the mapping device 22 is removed from the patient and after the mapping device 22 has been removed from the patient.

An implantable device (not shown in fig. 1) including an implantable electrode is aligned on the baroreceptor region using marker 26, with the implantable electrode positioned at the identified active location. Implantable devices are sutured into place on the baroreceptor region and implantable electrodes are used to stimulate the baroreceptors at the identified active locations to relieve overstrain. After the implantable device is attached to the patient, the marker 26 is removed from the patient. In some embodiments, multiple markers may be used to keep track of the identified valid locations on the baroreceptor region. In some embodiments, marker 26 comprises a peg. In some embodiments, the marker 26 comprises a thread sewn into place.

In one example, the controller 40 controls the switches 44 to selectively connect two of the mapping electrodes 28 to the pulse generator 42. The controller 40 controls the switch 44 to connect one of the mapping electrodes 28 as a cathode to the pulse generator 42 and the other of the mapping electrodes 28 as an anode to the pulse generator 42. The controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 28 to provide unipolar or bipolar electrical stimulation to the tissue of the baroreceptor region through the mapping electrodes 28. The patient provides a physiological response, such as a change in blood pressure and a change in heart rate, that is primarily responsive to stimulation of the tissue beneath the cathode. In some embodiments, the pulse generator 42 provides a current through the mapping electrode 28 between 2 and 5 milliamps (mA) to stimulate the patient. In some embodiments, the pulse generator 42 provides a current through the mapping electrode 28 between 2.9mA and 4.1mA to stimulate the patient. In some embodiments, the pulse generator 42 provides current for a period of time less than 5 seconds. In some embodiments, the patient's blood pressure and heart rate begin to change within 5 seconds of the beginning of the electrical stimulation, and the measurement of the change ends 1 minute or less after the stimulation has begun.

To further illustrate this example, the controller 40 receives signals from the sensor 36 indicative of the patient's blood pressure and heart rate, and the controller 40 analyzes the signals to obtain a reduction in the patient's blood pressure and heart rate. The controller 40 stores the data in a map of the baroreceptor region, indicating the stimulated cathode electrodes and corresponding physiological responses. To analyze the map of the baroreceptor region, the controller 40 compares the magnitude of the decrease in blood pressure and heart rate at one cathode electrode to the decrease at the other cathode electrode. The controller 40 selects the cathode electrode that provides the largest change to obtain a location of the one mapping electrode 28 that provides a valid physiological response when stimulated. In some embodiments, controller 40 may include a tie-breaking scheme, such as selecting the cathode electrode that provides the greatest reduction in blood pressure versus the cathode electrode that provides the greatest reduction in heart rate.

Additionally, in this example, markers 26 are attached to the patient to mark the position of the selected mapping electrode 28 and to keep track of the identified valid locations on the baroreceptor region. The marker 26 maintains its position on the patient when the mapping device 22 is removed from the patient and after the mapping device 22 has been removed from the patient. Next, an implantable device comprising an implantable electrode is aligned on the baroreceptor region using marker 26, wherein the implantable electrode is placed at the identified active location. Implantable devices are sutured into place on the baroreceptor region and implantable electrodes are used to stimulate the baroreceptors at the identified active locations to relieve overstrain. After the implantable device is attached to the patient, the marker 26 is removed from the patient.

Fig. 2 is a schematic diagram illustrating a mapping device 100 and a marker 102 placed on an artery 104, according to some embodiments described in this disclosure. The mapping device 100 and the markers 102 may be attached to an artery 104. In some embodiments, mapping device 100 is similar to mapping device 22 (shown in fig. 1). In some embodiments, marker 102 is similar to marker 26 (shown in fig. 1).

The mapping device 100 may be attached to the artery 104 to map the baroreceptor region of the artery 104. The mapping device 100 has a first side facing the artery 104 and a second side opposite the first side and facing away from the artery 104. In some embodiments, the mapping device 100 is wrapped or wrapped around the artery 104 to hold the mapping device 100 in place on the artery 104. In some embodiments, the mapping device 100 includes a self-wrapping sheet that wraps the mapping device 100 around the artery 104 and secures the mapping device 100 to the baroreceptor region. In some embodiments, the backing of the mapping device 100 is formed to wrap the mapping device 100 around the artery 104 and secure the mapping device 100 to the baroreceptor region.

The mapping apparatus 100 includes a plurality of mapping electrodes 106 formed on a substrate 108. The mapping electrodes 106 may be arranged in an array of mapping electrodes 106. The substrate 108 comprises at least one insulating layer on a first side of the mapping device 100, and the mapping electrodes 106 are formed on the insulating layer of the substrate 108. The mapping electrode 106 is placed on a first side of the substrate 108 to face the artery 104 and contact the tissue of the baroreceptor region. In some embodiments, the substrate 108 is formed to wrap the mapping device 100 around the artery 104 and secure the mapping device 100 to the baroreceptor region. In some embodiments, the mapping device 100 is configured to wrap completely around the artery 104 and hold the mapping electrode 106 in place on the baroreceptor region. In some embodiments, the mapping device 100 is configured to partially wrap around the artery 104 and hold the mapping electrode 106 in place on the baroreceptor region. In some embodiments, the mapping device 100 is configured to be pressed against the artery 104 and hold the mapping electrode 106 in place on the baroreceptor region.

Mapping electrode 106 is made of an electrically conductive material and is electrically coupled to a mapping device cable 110, which is electrically coupled to a stimulator, such as stimulator 24 (shown in fig. 1). In some embodiments, the mapping electrode 106 comprises a metal. In some embodiments, the mapping electrode 106 comprises copper. In some embodiments, each of the mapping electrodes 106 is electrically isolated from other mapping electrodes 106 on the substrate 108. In some embodiments, the mapping device 100 is constructed using printed circuit board technology.

A marker 102 is attached to the artery 104 to indicate and keep track of the identified effective location in the baroreceptor region to stimulate the baroreceptor region and obtain a desired physiological response from the patient. The marker 102 is attached to the artery 104 relative to the mapping device 100. In some embodiments, a plurality of markers, such as marker 102, may be attached to artery 104 relative to mapping device 100 to indicate and keep track of the identified valid locations in the baroreceptor region.

The marker 102 may be attached to the tissue of the artery 104 through a marked orifice in the mapping device 100 or at one or more locations near the mapping device 100. The indicia aperture may be a through-hole aperture in the mapping device 100 that extends completely through the mapping device 100 from a first side of the mapping device 100 to a second side of the mapping device 100. In some embodiments, the mapping device 100 includes a through-hole aperture through each of the plurality of mapping electrodes 106, and the marker 102 is attached to the artery 104 through one of the through-hole apertures. In some embodiments, the mapping device 100 includes a through-hole aperture proximate each of the plurality of electrodes 106, and the marker 102 is attached to the artery 104 through one of the through-hole apertures. In some embodiments, the mapping device 100 includes one or more through-hole apertures at the periphery of the mapping device 100 external to the plurality of mapping electrodes 106, and one or more markers, such as marker 102, are attached to the artery 104 through the through-hole apertures.

Fig. 3 is a schematic diagram illustrating a mapping apparatus 120 including a mapping electrode region 122 as indicated by a dotted line and a peripheral region 124 outside the mapping electrode region 122 according to some embodiments described in the present disclosure. In some embodiments, mapping device 120 is similar to mapping device 100.

The mapping electrode region 122 includes a mapping electrode 128, and the peripheral region 124 includes a through-hole aperture 126 extending through the mapping device 120. A marker, such as marker 102, may be attached to the tissue of the baroreceptor region through the through-hole aperture 126 in the peripheral region 124 to indicate and keep track of the identified active location in the baroreceptor region. In some embodiments, the mapping electrode 128 is similar to the mapping electrode 106.

Fig. 4 is a schematic diagram illustrating a mapping apparatus 130 and a marker 132 according to some embodiments described in the present disclosure. The mapping device 130 includes a mapping electrode 134 made of a conductive material and includes a conductive wire 136 that can be electrically coupled to a mapping device cable, such as the mapping device cable 110. In some embodiments, mapping device 130 is similar to mapping device 100. In some embodiments, marker 132 is similar to marker 102. In some embodiments, the mapping electrodes 134 are similar to at least one of the mapping electrodes 106. In some embodiments, the mapping electrodes 134 are similar to each and every one of the mapping electrodes 106.

The mapping electrodes 134 are shaped to provide stimulation to the tissue of the baroreceptor region. The mapping electrode 134 has a circular shape and the mapping device 130 includes a through-hole aperture 138 extending through an interior region 140 of the mapping electrode 134. This results in the mapping electrode 134 having a circular closed curve shape or a ring coil shape, wherein the inner region 140 of the mapping electrode 134 comprises a via aperture 138, the via aperture 138 being surrounded by the conductive material of the mapping electrode 134. The marker 132 may be attached to the tissue of the baroreceptor region through the through-hole aperture 138. In some embodiments, mapping electrodes 134 have different closed curve shapes, such as a rectangular closed curve shape or a hexagonal closed curve shape. In some embodiments, the via aperture 138 extends through the mapping device 130 proximate to the mapping electrode 134, but not through the interior region 140 of the mapping electrode 134.

Fig. 5 is a schematic diagram illustrating a mapping device 150 and a marker 152 according to some embodiments described in the present disclosure, wherein the mapping device 150 includes a through-hole aperture 158 extending through the mapping device 150 proximate to the mapping electrode 154. The mapping device 150 includes a mapping electrode 154 made of a conductive material and includes a conductive wire 156 that can be electrically coupled to a mapping device cable, such as the mapping device cable 110. In some embodiments, mapping device 150 is similar to mapping device 100. In some embodiments, marker 152 is similar to marker 102. In some embodiments, the mapping electrodes 154 are similar to at least one of the mapping electrodes 106. In some embodiments, the mapping electrodes 154 are similar to each and every one of the mapping electrodes 106.

The mapping electrodes 154 are shaped to provide stimulation to the tissue of the baroreceptor region. The mapping electrode 154 has a circular shape and the mapping device 150 includes a through-hole aperture 158 positioned proximate to the mapping electrode 154. The marker 152 may be attached to the tissue of the baroreceptor region through the through-hole aperture 158. In some embodiments, the mapping electrodes 154 have different shapes, such as rectangular shapes or hexagonal shapes.

Fig. 6A-6F are schematic diagrams illustrating

different markers

170, 172, 174, 176, 178, and 180 that may be attached to a patient's tissue to indicate and keep track of identified valid locations in the baroreceptor region, according to some embodiments described in the present disclosure.

Fig. 6A is a schematic diagram illustrating a marker 170 having a straight spike shape according to some embodiments. The marker 170 includes an end 170a that is snapped into the patient's tissue. In some embodiments, the marker 170 is a rigid nail. In some embodiments, the marker 170 is a rigid nail comprising metal.

Fig. 6B is a schematic diagram illustrating a marker 172 having a straight spike shape and including an insertion stop 172a according to some embodiments. The marker 172 includes an end 172b that is inserted into the tissue of the patient, and the insertion stop 172a prevents or inhibits further insertion of the marker 172 into the patient. In some embodiments, the marker 172 including the insertion stop 172a is rigid. In some embodiments, at least the insertion stop 172a is flexible. In some embodiments, the marker 172 comprises a metal.

Fig. 6C is a schematic diagram illustrating a tag 174 with a hook 174a at one end 174b of the tag 174, according to some embodiments. The hook 174a is hooked through the patient's tissue to attach the marker 174 to the patient. In some embodiments, the marker 174 is rigid. In some embodiments, the marker 174 comprises a metal.

Fig. 6D is a schematic diagram illustrating a marker 176 having a hook 176a at one end 176b and including an insertion stop 176c according to some embodiments. The hook 176a is hooked through the patient's tissue to attach the marker 176 to the patient and the insertion stop 176c prevents or blocks further insertion of the marker 176 into the patient. In some embodiments, the marker 176 including the insertion stop 176c is rigid. In some embodiments, at least the insertion stop 176c is flexible. In some embodiments, marker 176 comprises a metal.

Fig. 6E is a schematic diagram illustrating a marker 178 having a helical structure 178a at one end 178b of the marker 178, according to some embodiments. The helical structure 178a is twisted into the patient's tissue to attach the marker 178 to the patient. In some embodiments, the marker 178 is rigid. In some embodiments, the marker 178 comprises a metal.

Fig. 6F is a schematic diagram illustrating a marker 180 having a helical structure 180a at one end 180b and including an insertion stop 180c according to some embodiments. The helical structure 180a is twisted into the patient's tissue to attach the marker 180 to the patient and the insertion stop 180c prevents or inhibits further insertion of the marker 180 into the patient. In some embodiments, the marker 180 including the insertion stop 180c is rigid. In some embodiments, at least the insertion stop 180c is flexible. In some embodiments, the marker 180 comprises a metal.

Fig. 7A and 7B are schematic

diagrams illustrating markers

200 and 202 attached to

arteries

204 and 206, respectively, after a mapping device has been removed from

arteries

204 and 206, according to some embodiments described in the present disclosure. In some embodiments,

markers

200 and 202 are similar to marker 26 (shown in fig. 1). In some embodiments,

markers

200 and 202 are similar to marker 102 (shown in fig. 2).

As previously described, mapping devices such as mapping device 22 and mapping device 100 are used to map the baroreceptor region of the patient, and the mapping is analyzed to determine which of the mapping electrodes provides an effective physiological response when stimulated. The location of this mapping electrode on the baroreceptor region is referred to as the identified valid location in the baroreceptor region. At least one marker, such as marker 26 and marker 102, is attached to the patient to indicate and keep track of the identified valid location in the baroreceptor region. Markers are attached to the patient relative to the mapping device and the mapping electrodes that provide an effective physiological response when stimulated. The markers indicate and keep track of the identified valid locations in the baroreceptor region. The marker maintains its position on the patient when the mapping device is removed and after the mapping device has been removed from the patient.

Fig. 7B is a schematic diagram illustrating the marker 200 attached to the artery 204 after the mapping device has been removed from the artery 204, according to some embodiments. The marker 200 may be one of the

markers

170, 172, 174, and 176.

In some embodiments, the marker 200 is attached to the tissue of the artery 204 by a through-hole aperture, such as the through-hole aperture 138 extending through the mapping electrode 134 (shown in fig. 4). The mapping electrode 134 may have been identified as the mapping electrode that provides the most effective physiological response when stimulated, and the marker 200 is attached to the baroreceptor region at the identified effective location in the baroreceptor region of the patient.

In some embodiments, the marker 200 is attached to the tissue of the artery 204 through a through-hole aperture, such as the through-hole aperture 158 proximate to the mapping electrode 154 (shown in fig. 5). The mapping electrode 154 may have been identified as the mapping electrode that provides the most effective physiological response when stimulated, and the marker 200 is attached to the baroreceptor region directly above the identified effective location in the baroreceptor region of the patient.

Fig. 7B is a schematic diagram illustrating the marker 202 attached to the artery 206 after the mapping device has been removed from the artery 206, in accordance with some embodiments. The marker 202 is a thread that has been sutured into the tissue of the artery 206.

In some embodiments, the marker 202 is attached to the tissue of the artery 206 by a through-hole aperture, such as the through-hole aperture 138 extending through the mapping electrode 134 (shown in fig. 4). The mapping electrode 134 may have been identified as the mapping electrode that provides the most effective physiological response when stimulated, and the marker 202 is attached to the baroreceptor region at the identified effective location in the baroreceptor region of the patient.

In some embodiments, the marker 202 is attached to the tissue of the artery 206 through a through-hole aperture, such as the through-hole aperture 158 proximate to the mapping electrode 154 (shown in fig. 5). The mapping electrode 154 may have been identified as the mapping electrode that provides the most effective physiological response when stimulated, and the marker 202 is attached to the baroreceptor region directly above the identified effective location in the baroreceptor region of the patient.

In some embodiments, one or more markers, such as marker 200 and marker 202, are attached to the tissue of

arteries

204 and 206 through one or more through-hole apertures in the mapping device. In some embodiments, one or more markers, such as marker 200 and marker 202, are attached to the tissue of

arteries

204 and 206 through one or more through-hole apertures in the periphery of the mapping device. In some embodiments, one or more markers, such as marker 200 and marker 202, are attached to tissue

proximate arteries

204 and 206 of the mapping device.

Fig. 8 is a schematic diagram illustrating an implantable device 220 and a marker 222 attached to an artery 224 according to some embodiments described in the present disclosure. The implantable device 220 can be sutured to the artery 224 to provide long-term stimulation of the baroreceptors at the identified effective locations in the baroreceptor region. In some embodiments, the implantable medical device is electrically coupled to the implantable device 220 to provide electrical stimulation to the patient.

Markers 222 are attached to the arteries 224 to indicate and keep track of the identified valid locations in the baroreceptor region. In some embodiments, multiple markers, such as marker 222, may be attached to artery 224 to indicate and keep track of the identified valid locations in the baroreceptor region. In some embodiments, markers 222 are similar to one or more of the markers described in the present disclosure, including

markers

26, 102, 132, 152, 170, 172, 174, 176, 200, and 202.

The implantable device 220 has a first side facing the artery 224 and a second side opposite the first side and facing away from the artery 224. The implantable device 220 includes one or more implantable electrodes 226 formed on a substrate 228. The substrate 228 includes at least one insulating layer on a first side of the implantable device 220, and the implantable electrode 226 is formed on the insulating layer of the substrate 228. Implantable electrodes 226 are disposed on the first face to face the artery 224 and contact tissue of the baroreceptor region. In some embodiments, each of the implantable electrodes 226 is electrically isolated from other implantable electrodes 226 on the substrate 228. In some embodiments, implantable device 220 is constructed using printed circuit board technology.

The implantable electrode 226 is made of an electrically conductive material and is electrically coupled to an implantable device cable 230, which may be electrically coupled to a stimulator of a stimulator in the implantable medical device. In some embodiments, the implantable electrode 226 comprises a metal. In some embodiments, the implantable electrode 226 comprises copper.

The implantable device 220 is aligned over the artery 224 using the marker 222, and one of the implantable electrodes 226 is placed in the identified active position. The implantable device 220 is sutured into place in the artery 224 with sutures 232, and implantable electrodes 226 are used to provide stimulation of baroreceptors at the identified active locations in the baroreceptor region. After the implantable device 220 is attached to the patient, the marker 222 is removed from the patient. In some embodiments, multiple markers may be used to keep track of the identified effective location on the baroreceptor region and removed after the implantable device 220 is attached to the patient.

In some embodiments, the implantable device 220 includes an alignment aperture that slides over a marker 222 attached to the patient. The marker 222 is slid through the alignment aperture to align one of the implantable device 220 and the implantable electrode 226 in the identified active position in the baroreceptor region. The marker aperture may be a through-hole aperture in the implantable device 220 that extends completely through the implantable device 220 from a first face of the implantable device 220 to a second face of the implantable device 220. In some embodiments, the implantable device 220 includes a through-hole aperture through each of the implantable electrodes 226, and the marker 224 is slid through one of the through-hole apertures to align the implantable device 220 over the artery 224. In some embodiments, the implantable device 220 includes a through-hole aperture proximate each of the implantable electrodes 226, and the marker 222 is slid through one of the through-hole apertures to align the implantable device 220 over the artery 224. In some embodiments, the implantable device 220 includes one or more through-hole apertures at the outer periphery of the implantable device 220 outside the implantable electrode 226, and one or more markers, such as marker 222, are slid through one or more of the through-hole apertures to align the implantable device 220 over the artery 224.

Fig. 9 is a schematic diagram illustrating an implantable device 240 including implantable electrode regions 242 as indicated by the dashed lines and a peripheral region 244 outside of the implantable electrode regions 242 according to some embodiments described in the present disclosure. In some embodiments, implantable device 240 is similar to implantable device 220.

The implantable electrode regions 242 include implantable electrodes, such as implantable electrodes 226, and the peripheral region 244 includes a through-hole aperture 246 extending through the implantable device 240. A marker, such as marker 222, can be slid through one or more of the through-hole apertures 246 to align the implantable device 240 on the patient.

Fig. 10 is a schematic diagram illustrating an implantable device 250 and a marker 252 according to some embodiments described in the present disclosure. The implantable device 250 includes an implantable electrode 254 made of a conductive material and includes a conductive lead 256 configured to electrically couple to an implantable device cable, such as implantable device cable 230. In some embodiments, implantable device 250 is similar to implantable device 220. In some embodiments, marker 252 is similar to marker 222. In some embodiments, the implantable electrodes 254 are similar to at least one of the implantable electrodes 226. In some embodiments, implantable electrodes 254 are similar to each and every one of implantable electrodes 226.

The implantable electrode 254 is shaped to provide stimulation to the tissue of the baroreceptor region. The implantable electrode 254 has a circular shape and the implantable device 250 includes a through-hole aperture 258 extending through an interior region 260 of the implantable electrode 254. This results in the implantable electrode 254 having a circular closed curve shape or a looped coil shape, wherein an interior region 260 of the implantable electrode 254 includes a through-hole aperture 258, the through-hole aperture 138 being surrounded by the conductive material of the implantable electrode 254. The marker 252 is slid through the through-hole aperture 258 to align the implantable device 250 and implantable electrode 256 in the identified active position in the baroreceptor region. In some embodiments, the implantable electrode 254 has a different closed curve shape, such as a rectangular closed curve shape or a hexagonal closed curve shape. In some embodiments, the through-hole aperture 258 extends through the implantable device 250 proximate the implantable electrode 254, but not through the interior region 260 of the implantable electrode 254.

Fig. 11 is a schematic diagram illustrating an implantable device 270 and marker 272 according to some embodiments described in the present disclosure, wherein the implantable device 270 includes a through-hole aperture 278 extending through the implantable device 270 proximate to an implantable electrode 274. The implantable device 270 includes an implantable electrode 274 made of a conductive material and includes a conductive lead 276 capable of electrically coupling to an implantable device cable, such as implantable device cable 230. In some embodiments, implantable device 270 is similar to implantable device 220. In some embodiments, marker 272 is similar to marker 222. In some embodiments, implantable electrode 274 is similar to at least one of implantable electrodes 226. In some embodiments, implantable electrodes 274 are similar to each and every one of implantable electrodes 226.

Implantable electrode 274 is shaped to provide stimulation to the tissue of the baroreceptor region. The implantable electrode 274 has a circular shape and the implantable device 270 includes a through-hole aperture 278 disposed proximate the implantable electrode 274. The marker 272 is slid through the through-hole aperture 278 to align the implantable device 270 and implantable electrode 276 in the identified effective position in the baroreceptor region. In some embodiments, the implantable electrode 274 has a different shape, such as a rectangular shape or a hexagonal shape.

Fig. 12 is a schematic diagram illustrating an example of an implantable system 300 coupled to an implantable device 302 for long-term stimulation of baroreceptors at identified effective locations in a baroreceptor region of a patient according to some embodiments described in the present disclosure. The implantable system 300 can be electrically coupled to any of the implantable devices described in this disclosure, including

implantable devices

220, 240, 250, and 270, to provide electrical stimulation to baroreceptors in the baroreceptor region. The implantable system 300 may be used to provide electrical stimulation to baroreceptors in a baroreceptor region (e.g., the carotid sinus of the ICA, the carotid sinus of the ECA, a region near the bifurcation of the ICA and the ECA, the arch of the aorta, and others).

Implantable system 300 includes an implantable device 302, an Implantable Medical Device (IMD) stimulator 304, and a sensor 306. Implantable device 302 is similar to one or more of

implantable devices

220, 240, 250, and 270, and is electrically coupled to IMD stimulator 304 by implantable device cable 308.

IMD stimulator 304 includes IMD controller 310, IMD pulse generator 312, and IMD switch 314. The controller 310 is communicatively coupled to the pulse generator 312 via a communication path 316 and to the switch 314 via a communication path 318. The pulse generator 312 is electrically coupled to the switch 314 via a conductive path 320, and the switch 314 is electrically coupled to the implantable device 302 via a conductive path 322 and the cable 308. Further, controller 310 is communicatively coupled to sensor 306 via communication path 324.

The controller 310 receives signals from the sensors 306 that indicate the physiological state of the patient. The controller 310 analyzes the signal to determine whether the patient requires electrical stimulation by the implantable device 302 and, if so, to determine parameters of the electrical stimulation including one or more of amplitude, pulse width, pulse frequency, burst duration of the pulse sequence, burst cycle duration, and duty cycle. In some embodiments, the controller 310 stores physiological parameters obtained from the patient via the sensor 306.

The controller 310 controls the switch 314 to selectively connect one or more implantable electrodes in the implantable device 302 to the pulse generator 312, and the controller 310 controls the pulse generator 312 to stimulate the connected implantable electrodes. In some embodiments, controller 310 controls switch 314 to connect one or more of the implantable electrodes as a cathode to pulse generator 312 and/or as an anode to one or more of the implantable electrodes. In some embodiments, the pulse generator 312 controls the switch 314 to connect two or more of the implantable electrodes to the pulse generator 312 for bipolar stimulation, i.e., at least one cathodic electrode and at least one anodic electrode. In some embodiments, the controller 310 controls the switch 314 to connect one implantable electrode to the pulse generator 312 for unipolar stimulation.

The method includes, at 340, the step of maintaining a mapping device on the baroreceptor region. The mapping device includes a plurality of mapping electrodes positioned on the baroreceptor region. In some embodiments, the mapping device is similar to one or more of

mapping devices

22, 100, 120, 130, 150, and 404. In some embodiments, the mapping device is a self-wrapping mapping device wrapped around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region. In some embodiments, the backing of the mapping device is formed to wrap the mapping device around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region. In some embodiments, the substrate is formed to wrap the mapping device around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region. In some embodiments, the mapping device includes a self-wrapping sheet that wraps the mapping device around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region.

At 342, the method includes the step of stimulating selected ones of the plurality of mapping electrodes on the baroreceptor region with a stimulator, such as stimulator 24, to obtain a physiological response from the patient. The physiological response is in response to electrical stimulation of baroreceptors in a baroreceptor region below the stimulated mapping electrode.

In some embodiments, a sensor, such as sensor 36, senses at least one physiological parameter of the patient and provides a signal indicative of the sensed physiological parameter. The stimulator receives these signals and analyzes them to obtain a physiological response of the patient due to electrical stimulation of baroreceptors in the baroreceptor region below the stimulated mapping electrode. The stimulator stores the stimulated mapping electrodes and physiological response information in a map of the baroreceptor region. In some embodiments, the stimulator analyzes the map of baroreceptor regions to identify locations of at least one of the selected electrodes that provide a valid physiological response when stimulated.

At 344, the method includes the step of marking a location of at least one of the selected mapping electrodes on the baroreceptor region of the patient with a marker based on the analysis of the physiological response from the patient. The position of the marker relative to the mapping device and at least one mapping electrode that provides an effective physiological response when stimulated is attached to the patient. In some embodiments, the marker is attached to the patient by at least one marker aperture extending through the mapping device. In some embodiments, marking the location includes inserting a staple into the patient through at least one marking aperture extending through the mapping device. In some embodiments, marking the location comprises suturing the thread into the patient through at least one marking aperture extending through the mapping device.

Next, at 346, the method includes the step of removing the mapping device from the patient, and at 348 maintaining markers on the patient to mark the position of the at least one mapping electrode on the baroreceptor region of the patient. In some embodiments, the marker is maintained on the patient via a hook at one end of the marker.

At 350, the method includes the step of aligning the implantable device on the baroreceptor region using the attached marker. In some embodiments, aligning the implantable device on the baroreceptor region includes positioning a marker through at least one alignment aperture extending through the implantable device. In some embodiments, the marker is a peg and aligning the implantable device on the baroreceptor region includes positioning the peg through at least one alignment aperture extending through the implantable device. In some embodiments, the marker is a suture and aligning the implantable device on the baroreceptor region includes positioning a wire through at least one alignment aperture extending through the implantable device.

At 352, the method includes the step of securing an implantable device to the patient that is aligned with the marker on the baroreceptor region. Wherein, in some embodiments, securing the implantable device to the patient comprises suturing the implantable device to the patient. At 354, the method includes the step of removing the marker from the patient.

Fig. 14-18 are schematic diagrams illustrating a method of attaching a mapping device 400 to a self-wrapping silicone sheet 402 to produce a self-wrapping mapping device 404, according to some embodiments described in this disclosure. The self-wrapping mapping device 404 may be wrapped or wrapped around a body part such as an artery to hold the mapping electrode 406 on the baroreceptor region. In some embodiments, the self-winding mapping device 404 is similar to one or more of the mapping devices described in this disclosure, including

mapping devices

22, 100, 120, 130, and 150.

Fig. 14 is a schematic diagram illustrating a mapping device 400 before attaching a self-wrapping silicone sheet 402 according to some embodiments. The mapping device 400 includes a mapping electrode 406 electrically coupled to a mapping device cable 408.

Fig. 15 is a schematic diagram illustrating a self-wrapping silicone sheet 402 according to some embodiments. The self-wrapping silicone sheet 402 is unrolled and staked or staked into a flat surface by stakes 410. A layer of silicone adhesive 412 is applied to at least part of the inward wound portion of the self-wound silicone sheet 402 to attach the mapping device 400.

Fig. 16 is a schematic diagram illustrating a mapping device 400 attached to a self-wrapping silicone sheet 402 by a silicone adhesive 412, according to some embodiments. The mapping device 400 is laminated to the flattened self-wrapping silicone sheet 402 via a silicone adhesive 412. In some embodiments, the laminated assembly is then wound around a mandrel to allow the unprocessed silicone adhesive 412 to be processed in a wound state, thereby properly seating the mapping device 400 and setting the winding permanent. After the machining process, the self-wrapping mapping device 404 is unwrapped and the outer perimeter of the self-wrapping silicone sheet 402 is trimmed away to best fit or grip onto the patient's body part.

Fig. 17 is a schematic diagram illustrating a flattened self-wrapping mapping device 404 that cuts off excess amounts of self-wrapping silicone sheet 402, in accordance with some embodiments.

Fig. 18 is a schematic diagram illustrating a wound self-winding mapping device 404 according to some embodiments. The self-winding mapping device 404 is unwound during surgery and rewound around a body part such as an artery to establish mechanical fixation or grip onto the artery.

Fig. 19 is a flow chart illustrating a method of generating the self-wrapping map device 404 according to some embodiments described in this disclosure.

At 420, the method includes the step of unrolling and stapling the self-wrapping silicone sheet 402 into a flat surface. Self-wrapping silicone sheet 402 may be stapled to a flat surface with pegs 410. At 422, a layer of silicone adhesive 412 is applied to at least part of the inward wrapped portion of the self-wrapping silicone sheet 402 to attach the mapping device 400.

At 424, the method includes the step of laminating or bonding the mapping device 400 to the flattened self-wrapping silicone sheet 402 via the silicone adhesive 412. At 426, the method includes the step of winding the laminate assembly around a mandrel to allow the unprocessed silicone adhesive 412 to be processed in a wound state, thereby properly seating the mapping device 400 and setting the winding permanent.

At 428, the method includes the steps of unwinding the windings of the self-winding mapping device 404 and trimming off excess amounts of the self-winding silicone sheet 402. The self-wrapping mapping device 404 is unwrapped and rewound around a body part of the patient, such as an artery, during surgery to establish mechanical fixation or grip on the artery.

Alternatively, in some embodiments, the backing of the mapping device is formed to provide a self-wrapping mapping device that can be wrapped or wrapped around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region. In some embodiments, the substrate of the mapping device, such as substrate 108, is formed to provide a self-wrapping mapping device capable of wrapping or wrapping the mapping device around at least one portion of the patient (e.g., an artery) to maintain the mapping device and the mapping electrodes on the baroreceptor region.

Some advantages of self-winding mapping devices, such as self-winding mapping device 404, include: a method of securing a self-winding mapping device to a patient during a mapping procedure without manually holding the mapping device in place; a method of securing a self-wrapping mapping device in place during a mapping process without the use of sutures; a self-wrapping mapping device that stabilizes in its position on a patient, thereby reducing or eliminating electrical noise caused by movement of the self-wrapping mapping device during a mapping process; and a method of gripping that allows easy repositioning on the patient.

Fig. 20-25 are schematic diagrams illustrating an algorithm for mapping baroreceptors in the baroreceptor region of a patient. Mapping may be accomplished with a stimulator, such as stimulator 24 (shown in fig. 1).

Fig. 20 is a schematic diagram illustrating a mapping apparatus 500 for mapping a targeted baroreceptor region, in accordance with some embodiments. Mapping device 500 includes a plurality of mapping electrodes 502 electrically coupled to stimulator 24 via a mapping device cable 504. In some embodiments, mapping device 500 is similar to one or more of the mapping devices described in this disclosure, including

mapping devices

22, 100, 120, 130, 150, and 404.

As used in this example, the stimulator 24 includes a stimulation controller 40, a stimulation pulse generator 42, and a switch 44. The controller 40 controls the switches 44 to selectively connect one or more of the mapping electrodes 502 as one or more cathodes to the pulse generator 42 and/or to selectively connect one or more of the mapping electrodes 502 as one or more anodes to the pulse generator 42. In addition, the controller 40 controls the pulse generator 42 to stimulate the baroreceptor region through the connected mapping electrodes 502, wherein the stimulation parameters may include one or more of amplitude, pulse width, pulse frequency, burst duration of a pulse sequence, burst cycle duration, and duty cycle. The controller 40 controls the pulse generator 42 to provide unipolar electrical stimulation to the tissue of the baroreceptor region through the mapping electrode 502 or bipolar electrical stimulation to the tissue of the baroreceptor region through the mapping electrode 502.

In some embodiments, to provide unipolar stimulation, the controller 40 controls the switch 44 to selectively connect one of the mapping electrodes 502 as a cathode to the pulse generator 42, and the controller 40 controls the pulse generator 42 to stimulate the baroreceptor region through the connected mapping electrode. The circuit path is complete through the patient's body to any suitable location on the patient.

In some embodiments, to provide bipolar stimulation, the controller 40 controls the switch 44 to selectively connect one of the mapping electrodes 502 as a cathode to the pulse generator 42 and the other of the mapping electrodes 502 as an anode to the pulse generator 42. The controller 40 controls the pulse generator 42 to provide bipolar stimulation to the baroreceptor region through the connected mapping electrodes 502, wherein the circuit path is complete from anode to cathode or from cathode to anode.

In this example, the controller 40 receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated ones of the mapping electrodes 502 and the corresponding physiological responses. In addition, the controller 40 analyzes the map of baroreceptor regions to determine which regions of the mapping electrodes 502 are most likely to include mapping electrodes of the mapping electrodes 502 that provide a valid physiological response when stimulated. The location of the mapping electrode is referred to herein as the identified valid location in the baroreceptor region.

To begin, stimulator 24 divides mapping device 500 into two regions of mapping electrode 502, as indicated by the dashed line at region 1 at 506 and region 2 at 508. Zone 1 at 506 includes a mapping electrode 502 in the upper half of mapping device 500, and zone 2 at 508 includes a mapping electrode 502 in the lower half of mapping device 500. Next, to map the baroreceptor region below mapping electrode 502 in zone 1 at 506, controller 40 controls switch 44 to connect one of mapping electrodes 502 in zone 1 at 506 as a cathode to pulse generator 42 and one or more of mapping electrodes in zone 2 at zone 508 as an anode to pulse generator 42. The controller 40 controls the pulse generator 42 to provide bipolar electrical stimulation to the baroreceptor region through the connected mapping electrodes 502. Alternatively, in some embodiments, the controller 40 and pulse generator 42 provide unipolar stimulation to one of the mapping electrodes 502 connected as a cathode.

The controller receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient in response to stimulation of the baroreceptor region beneath the cathodically connected mapping electrode. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated cathodically connected mapping electrodes and corresponding physiological responses. This process is repeated for each of the mapping electrodes in zone 1 at 506 to complete the mapping of the baroreceptor region below the mapping electrode in zone 1 at 506. In some embodiments, the process may be repeated for a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 1 at 506 to complete the mapping of the baroreceptor zone below the mapping electrodes in zone 1 at 506.

Next, to map the baroreceptor region below mapping electrode 502 in zone 2 at 508, controller 40 controls switch 44 to connect one of mapping electrodes 502 in zone 2 at 508 as a cathode to pulse generator 42 and one or more of mapping electrodes in zone 1 at zone 506 as an anode to pulse generator 42. The controller 40 controls the pulse generator 42 to provide bipolar electrical stimulation to the baroreceptor region through the connected mapping electrodes 502. Alternatively, in some embodiments, the controller 40 and pulse generator 42 provide unipolar stimulation to one of the mapping electrodes 502 connected as a cathode.

The controller 40 receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient in response to stimulation of the baroreceptor region beneath the cathodically connected mapping electrode. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated cathodically connected mapping electrodes and corresponding physiological responses. This process is repeated for each of the mapping electrodes in zone 2 at 508 to complete the mapping of the baroreceptor region below the mapping electrode in zone 2 at 508. In some embodiments, the process may be repeated for a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 2 at 508 to complete the mapping of the baroreceptor zone below the mapping electrodes in zone 2 at 508.

Next, controller 40 analyzes the map of baroreceptor regions to determine which of region 1 at 506 and region 2 at 508 is most likely to include one or more mapping electrodes that provide a valid physiological response when stimulated. The region most likely to include the mapping electrode is selected and the process continues. In some embodiments, the effective physiological response is a maximum reduction in blood pressure of the patient. In some embodiments, the effective physiological response is a maximum reduction in the heart rate of the patient. In some embodiments, the effective physiological response is the maximum change in tissue impedance of the patient.

In some embodiments, the controller 40 displays a map of baroreceptor regions, and after viewing the map of baroreceptor regions, the user selects one of the two regions. In some embodiments, the controller 40 selects the region most likely to include one or more mapping electrodes that provide a valid physiological response when stimulated. In some embodiments, the controller 40 selects a zone by comparing the individual physiological response value in one zone with the individual physiological response value in another zone and selecting the zone with the largest physiological response value. In some embodiments, the controller 40 selects the zone by averaging the individual physiological response values in one zone and averaging the individual physiological response values in another zone and selecting the zone having the largest average physiological response value. In some embodiments, the controller 40 selects a zone by summing the individual physiological response values in one zone and summing the individual physiological response values in another zone and selecting the zone with the largest sum.

Fig. 21 is a schematic diagram illustrating selection of zone 1 at 506 and division of zone 1 at 506 into zone 3 at 510 and zone 4 at 512 as indicated by the dashed lines and according to some embodiments described in this disclosure. Zone 3 at 510 includes mapping electrode 502 to the left of zone 1 at 506, and zone 4 at 512 includes mapping electrode 502 to the right of zone 1 at 506. Next, to map the baroreceptor region below mapping electrode 502 in zone 3 at 510, controller 40 controls switch 44 to connect one of mapping electrodes 502 in zone 3 at 510 as a cathode to pulse generator 42 and one or more of mapping electrodes in zone 4 at zone 512 as an anode to pulse generator 42. The controller 40 controls the pulse generator 42 to provide bipolar stimulation to the baroreceptor region through the connected mapping electrodes 502. Alternatively, in some embodiments, the controller 40 and pulse generator 42 provide unipolar stimulation to one of the mapping electrodes 502 connected as a cathode.

The controller receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient in response to stimulation of the baroreceptor region beneath the cathodically connected mapping electrode. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated cathodically connected mapping electrodes and corresponding physiological responses. This process is repeated for each of the mapping electrodes in zone 3 at 510 to complete the mapping of the baroreceptor region below the mapping electrode in zone 3 at 510. In some embodiments, the process may be repeated for a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 3 at 510 to complete the mapping of the baroreceptor zone below the mapping electrodes in zone 3 at 510.

Next, to map the baroreceptor region below mapping electrode 502 in zone 4 at 512, controller 40 controls switch 44 to connect one of mapping electrodes 502 in zone 4 at 512 as a cathode to pulse generator 42 and one or more of mapping electrodes in zone 3 at zone 510 as an anode to pulse generator 42. The controller 40 controls the pulse generator 42 to provide bipolar stimulation to the baroreceptor region through the connected mapping electrodes 502. Alternatively, in some embodiments, the controller 40 and pulse generator 42 provide unipolar stimulation to one of the mapping electrodes 502 connected as a cathode.

The controller receives signals from the sensors 36 and analyzes the signals to obtain a physiological response from the patient in response to stimulation of the baroreceptor region beneath the cathodically connected mapping electrode. The controller 40 stores data in the map of the baroreceptor region indicating the stimulated cathodically connected mapping electrodes and corresponding physiological responses. This process is repeated for each of the mapping electrodes in zone 4 at 512 to complete the mapping of the baroreceptor region below the mapping electrode in zone 4 at 512. In some embodiments, the process may be repeated for a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 4 at 512 to complete the mapping of the baroreceptor zone below the mapping electrodes in zone 4 at 512.

Next, controller 40 analyzes the map of baroreceptor regions to determine which of region 3 at 510 and region 4 at 512 is most likely to include one or more mapping electrodes that provide a valid physiological response when stimulated. The region most likely to include the mapping electrode is selected and the process continues. In some embodiments, the effective physiological response is a maximum reduction in blood pressure of the patient. In some embodiments, the effective physiological response is a maximum reduction in the heart rate of the patient. In some embodiments, the effective physiological response is the maximum change in tissue impedance of the patient.

Fig. 22 is a schematic diagram illustrating selection of zone 4 at 512 and division of zone 4 at 512 into zone 5 at 514 and zone 6 at 516 as indicated by the dashed lines and according to some embodiments described in this disclosure. Region 5 at 514 includes mapping electrode 502 in the upper half of region 4 at 512, and region 6 at 516 includes mapping electrode 502 in the lower half of region 4 at 512.

Next, controller 40 controls switch 44 and pulse generator 42 and receives signals from sensor 36 and analyzes the signals, as described above, to map the baroreceptor region under mapping electrode 502 in zone 5 at 514 and in zone 6 at 516. In some embodiments, controller 40 selects a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 5 at 514 to complete the mapping of the baroreceptor region below mapping electrode 502 in zone 5 at 514, and selects a selected number of mapping electrodes (e.g., two or three mapping electrodes) in zone 6 at 516 to complete the mapping of the baroreceptor region below mapping electrode 502 in zone 6 at 516.

In addition, controller 40 analyzes the map of baroreceptor regions to determine which of region 5 at 514 and region 6 at 516 is most likely to include one or more mapping electrodes that provide a valid physiological response when stimulated. The region most likely to include the mapping electrode is selected and the process continues. In some embodiments, the effective physiological response is a maximum reduction in blood pressure of the patient. In some embodiments, the effective physiological response is a maximum reduction in the heart rate of the patient. In some embodiments, the effective physiological response is the maximum change in tissue impedance of the patient.

Fig. 23 is a schematic diagram illustrating selection of zone 6 at 516 and division of zone 6 at 516 into zone 7 at 518 and zone 8 at 520 as indicated by the dashed lines and according to some embodiments described in this disclosure. Zone 7 at 518 includes mapping electrode 502 to the left of zone 6 at 516, and zone 8 at 520 includes mapping electrode 502 to the right of zone 6 at 516.

Next, controller 40 controls switch 44 and pulse generator 42 and receives signals from sensor 36 and analyzes the signals, as described above, to map the baroreceptor region in region 7 at 518 and under mapping electrode 502 at region 8 at 520. In some embodiments, controller 40 selects one mapping electrode in zone 7 at 518 to complete the mapping of the baroreceptor region below mapping electrode 502 in zone 7 at 518, and selects one mapping electrode in zone 8 at 520 to complete the mapping of the baroreceptor region below mapping electrode 502 in zone 8 at 520.

In addition, controller 40 analyzes the map of baroreceptor regions to determine which of region 7 at 518 and region 8 at 520 most likely includes one or more mapping electrodes that provide a valid physiological response (which may be a greater or greatest physiological response) when stimulated. The region most likely to include the mapping electrode is selected and the process continues. In some embodiments, the effective physiological response is a maximum reduction in blood pressure of the patient. In some embodiments, the effective physiological response is a maximum reduction in the heart rate of the patient. In some embodiments, the effective physiological response is the maximum change in tissue impedance of the patient.

Fig. 24 is a schematic diagram illustrating selection of zone 7 at 518 and division of zone 7 at 518 into zone 9 at 522 and zone 10 at 524 as indicated by the dashed lines and according to some embodiments described in this disclosure. Region 9 at 522 includes one mapping electrode 502 in the upper half of region 7 at 518, and region 10 at 524 includes another mapping electrode 502 in the lower half of region 7 at 518.

Next, controller 40 controls switch 44 and pulse generator 42 and receives signals from sensor 36 and analyzes the signals, as described above, to map the baroreceptor region under mapping electrode 502 in zone 9 at 522 and in zone 10 at 524. In addition, controller 40 analyzes the map of the baroreceptor region to determine which of the mapping electrodes in region 9 at 522 and region 10 at 524 is the mapping electrode that provides a valid physiological response when stimulated. The mapping electrode is selected and the marking and placement process of the implantable device continues. In some embodiments, the effective physiological response is a maximum reduction in blood pressure of the patient. In some embodiments, the effective physiological response is a maximum reduction in the heart rate of the patient. In some embodiments, the effective physiological response is the maximum change in tissue impedance of the patient.

Fig. 25 is a schematic diagram showing all of regions 1-10 and indicating selected regions with different cross-hatching for the refinement process of fig. 20-24, according to some embodiments described in the present disclosure. Zone 1 at 506 is selected versus zone 2 at 508, and zone 4 at 512 is selected versus zone 3 at 510. In addition, zone 6 at 516 is selected versus zone 5 at 514, and zone 7 at 518 is selected versus zone 8 at 520. To refine it down to one mapping electrode, either region 9 at 522 or region 10 at 524 is selected.

In some embodiments, the mapping process described above with reference to fig. 20-25 may be interrupted at any point in the process and the user may stimulate and/or select the mapping electrodes 502 as desired by the user.

In one example, the controller 40 controls the pulse generator 42 to stimulate the selected mapping electrode 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's blood pressure, and the controller 40 analyzes the signal to obtain a reduction in the patient's blood pressure. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding decrease in blood pressure. The controller 40 determines a first average of the reduction of blood pressure in one zone and a second average of the reduction of blood pressure in another zone. The controller 40 selects the region with the largest or highest average decrease in blood pressure.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's heart rate, and the controller 40 analyzes the signal to obtain a reduction in the patient's heart rate. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding reduction in heart rate. The controller 40 determines a first average of the reduction of the heart rate in one zone and a second average of the reduction of the heart rate in another zone. The controller 40 selects the zone having the largest or highest average reduction in heart rate.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's blood pressure, and the controller 40 analyzes the signal to obtain a reduction in the patient's blood pressure. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding decrease in blood pressure. The controller 40 determines a first average of the reduction of blood pressure in one zone and a second average of the reduction of blood pressure in another zone. The user selects the region with the largest or highest average reduction in blood pressure.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's heart rate, and the controller 40 analyzes the signal to obtain a reduction in the patient's heart rate. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding reduction in heart rate. The controller 40 determines a first average of the reduction of the heart rate in one zone and a second average of the reduction of the heart rate in another zone. The user selects the zone with the largest or highest average reduction in heart rate.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's blood pressure, and the controller 40 analyzes the signal to obtain a reduction in the patient's blood pressure. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding decrease in blood pressure. The controller 40 compares the reduction in blood pressure in one zone with the reduction in blood pressure in another zone and selects the zone with the largest or highest reduction in blood pressure.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's heart rate, and the controller 40 analyzes the signal to obtain a reduction in the patient's heart rate. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding reduction in heart rate. The controller 40 compares the reduction in heart rate in one zone with the reduction in heart rate in another zone and selects the zone with the largest or highest reduction in heart rate.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's blood pressure, and the controller 40 analyzes the signal to obtain a reduction in the patient's blood pressure. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding decrease in blood pressure. The user compares the reduction in blood pressure in one zone with the reduction in blood pressure in another zone and selects the zone with the largest or highest reduction in blood pressure.

In one example, the controller 40 controls the pulse generator 42 to stimulate the connected mapping electrodes 502. The controller 40 receives a signal from the sensor 36 indicative of the patient's heart rate, and the controller 40 analyzes the signal to obtain a reduction in the patient's heart rate. The controller 40 stores the data in a map of the baroreceptor region, indicating a stimulated cathode electrode and a corresponding reduction in heart rate. The user compares the reduction in heart rate in one zone with the reduction in heart rate in another zone and selects the zone with the largest or highest reduction in heart rate.

26A-26C are flow diagrams illustrating a mapping algorithm for mapping a baroreceptor region according to some embodiments described in the present disclosure. A mapping device, such as one of the

mapping devices

22, 100, 120, 130, 150, and 404, is placed on the patient for mapping the baroreceptor region of the patient. A stimulator, such as stimulator 24, provides a mapping algorithm.

At 540, the stimulator divides the mapping device into two regions of mapping electrodes. At 542, the stimulator connects one of the mapping electrodes in one zone as a cathode to a pulse generator, such as pulse generator 42, and at 544, the stimulator connects one or more of the mapping electrodes in another zone as an anode to the pulse generator. The stimulator may anodically connect any one of the mapping electrodes in the other zone or any combination of the mapping electrodes in the other zone. In some embodiments, the surface patch is placed on the patient's skin and the stimulator is connected to the surface patch as an anode. In some embodiments, the stimulator connection may be part of the mapping device or a separate electrode from a separate probe that acts as an anode.

At 546, the stimulator controls the pulse generator to provide bipolar electrical stimulation to the baroreceptor region below the cathodically connected mapping electrode through the cathodically and anodically connected mapping electrode. Alternatively, in some embodiments, the stimulator controls the pulse generator to provide unipolar electrical stimulation to the baroreceptor region below the cathodically connected mapping electrode using the cathodically connected mapping electrode.

At 548, a physiological response associated with electrical stimulation of the baroreceptor region below the cathodically connected mapping electrode is obtained from the patient. The physiological response is obtained manually by the user or automatically using a stimulator and attached sensors. Further, at 550, the identity of the cathodically connected mapping electrodes and associated physiological response information is stored in the map of the baroreceptor region, either manually by the user or automatically with the stimulator.

If one or more of the mapping electrodes in one zone remain connected as cathodes at 552, the stimulator proceeds to connect a different one of the mapping electrodes in one zone as a cathode at 554 and the process repeats itself by the steps of providing electrical stimulation at 546, obtaining the associated physiological response at 548, and storing the identification of the stimulated cathode-connected mapping electrode and the associated physiological response at 550.

If all or a selected number of the mapping electrodes in one zone have been stimulated and mapped at 552, the stimulator proceeds to connect one of the mapping electrodes in the other zone as a cathode to the pulse generator at 556, and at 558, the stimulator connects one or more of the mapping electrodes in the (just mapped) one zone as an anode to the pulse generator. The stimulator may anodically connect any one of the mapping electrodes in the just-mapped zone or any combination of the mapping electrodes in the just-mapped zone. In some embodiments, the stimulator may be connected to a surface patch on the skin of the patient that acts as an anode. In some embodiments, the stimulator may be connected as part of the mapping device or as a separate electrode from a separate probe that acts as an anode.

At 560, the stimulator controls the pulse generator to provide bipolar electrical stimulation to the baroreceptor region below the cathodically connected mapping electrode through the cathodically and anodically connected mapping electrode. Alternatively, in some embodiments, the stimulator controls the pulse generator to provide unipolar electrical stimulation to the baroreceptor region below the cathodically connected mapping electrode using the cathodically connected mapping electrode.

At 562, a physiological response associated with electrical stimulation of the baroreceptor region under the cathodically connected mapping electrode is obtained from the patient either manually by the user or automatically with the stimulator and attached sensor. Further, at 564, the identity of the cathodically connected mapping electrode and associated physiological response information is stored in the map of the baroreceptor region, either manually by the user or automatically with the stimulator.

If one or more of the mapping electrodes in the other zone remain connected as a cathode at 566, the stimulator proceeds to connect a different one of the mapping electrodes in the other zone as a cathode at 568 and the process repeats itself by the steps of providing electrical stimulation at 560, obtaining the associated physiological response at 562, and storing the identification of the stimulated cathode-connected mapping electrode and the associated physiological response at 564.

If all or a selected number of the mapping electrodes in the other zone have been stimulated and mapped at 566, the process continues to analyze the mapping of the baroreceptor zone and select one zone or the other as including the most likely location for long-term stimulation of the baroreceptors in the baroreceptor zone at 572 at 570. In some embodiments, analyzing the mapping of the baroreceptor region at 570 may be done manually. In some embodiments, analyzing the mapping of the baroreceptor region at 570 can be done automatically with a stimulator.

In some embodiments, permanent implantable devices, such as

implantable devices

220, 240, 250, and 270, each have an implantable device electrode that is larger than one of the mapping electrodes. In some embodiments, the permanent implantable device has an implantable device electrode that is as large or larger than the combination of the plurality of mapping electrodes such that the implantable device electrode covers the same area on the baroreceptor region as the plurality of mapping electrodes. In the case where the implantable device electrode is larger than one of the mapping electrodes or covers the same area as the plurality of mapping electrodes, the selected final region may include the plurality of mapping electrodes and meet the needs of the system.

If the selected zone includes more than the number of mapping electrodes that meet the needs of the system at 574, the stimulator divides the selected zone into two zones at 576 and the process repeats itself from the step of connecting the mapping electrodes in one zone as cathodes to the pulse generator at 542. In some embodiments, when a zone is selected and the process repeats itself from the step of connecting the mapping electrode in one zone as a cathode to the pulse generator at 542, two or more physiological responses are obtained for the mapping electrode in that zone.

If the selected region includes a number of mapping electrodes or less than the number of mapping electrodes that meets the needs of the system at 574, the location of the region is a good candidate for the identified valid location of the baroreceptors in the baroreceptor region as indicated at 578. The process continues at 580 with marking the location. In some embodiments, the mapping process described above with reference to fig. 26A-26C is part of the method of fig. 13. In some embodiments, the mapping process described above with reference to fig. 26A-26C may be interrupted at any step in the process, and the user may stimulate and/or select one or more of the mapping electrodes as at the identified active locations on the baroreceptor region.

Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications and variances as fall within the scope of the claims along with all equivalents thereof.

Claims

1. A system for mapping and labeling baroreceptors in a baroreceptor region of a patient, comprising:

a mapping device comprising a plurality of apertures extending through the mapping device; and a plurality of electrodes configured to wrap at least partially around an artery and a baroreceptor region of a patient to map baroreceptors in the baroreceptor region;

a stimulator for stimulating selected electrodes of the plurality of electrodes to obtain a physiological response from the patient in response to stimulation of the selected electrodes; and

a marker having a length extending through an aperture of a plurality of apertures, and a distal end configured to be inserted through one of the plurality of apertures and into the patient to mark a location of at least one of the selected electrodes based on an analysis of the physiological response from the patient, the marker including a larger diameter portion near the distal end and configured to contact the patient and prevent further insertion of the marker into the patient, the distal end of the marker configured to maintain its position in the patient when the one of the plurality of apertures is removed from the length of the marker and the mapping device is removed from the patient.

2. The system of claim 1, comprising an implantable device including at least one implantable electrode to be aligned on the baroreceptor region using the marker.

3. The system of claim 1 or 2, wherein at least one of the plurality of electrodes has a closed curve mapping electrode shape including a marker aperture extending through an interior region of the closed curve mapping electrode shape.

4. The system of claim 2, wherein the implantable device includes at least one alignment aperture that extends through the implantable device and is to be aligned on the baroreceptor region via the marker and the at least one alignment aperture.

5. The system of claim 2, wherein the implantable device includes an implantable electrode having a closed curve implantable electrode shape and an alignment aperture extending through an interior region of the closed curve implantable electrode shape to be aligned on the baroreceptor region via the marker and the alignment aperture.

6. The system of any of claims 1, 2, 4, and 5, wherein the marker comprises at least one of a staple shape, a hook, and a suture for attaching the marker to the patient.

7. The system according to any one of claims 1, 2, 4 and 5, wherein the mapping device includes a self-winding sheet that secures the mapping device to the patient.

8. The system of any one of claims 1, 2, 4, and 5, comprising a sensor for sensing the physiological response and providing a signal indicative of the physiological response from the patient, wherein the stimulator receives the signal and analyzes the signal to determine a location of at least one of the selected electrodes to be labeled with the marker.

9. A system for mapping and labeling baroreceptors in a baroreceptor region of a patient, the system comprising:

a mapping device comprising a plurality of apertures extending through the mapping device; and a plurality of electrodes configured to wrap at least partially around an artery and the baroreceptor region of the patient;

a sensor for sensing a physiological parameter and providing a signal indicative thereof;

a controller for receiving the signals from the sensors and analyzing the signals to obtain physiological responses to stimulation of electrodes of the plurality of electrodes, the controller for storing data about the stimulated electrodes and corresponding physiological responses in the map of baroreceptor zones;

a marker having a length extending through a plurality of orifices, and a distal end configured to be inserted through one of the plurality of orifices and into the patient to mark a location of at least one of the electrodes that when stimulated provides an effective physiological response based on analysis of the mapping of the baroreceptor region, the marker including a larger diameter portion near the distal end and configured to contact the patient and prevent further insertion of the marker into the patient, the distal end of the marker configured to maintain its location in the patient when the one of the plurality of orifices is removed from the length of the marker and the mapping device is removed from the patient, and

an implantable device comprising at least one implantable electrode and at least one marker aperture through the implantable device, the marker aperture configured to be placed over a length of the marker to align the at least one implantable electrode on the baroreceptor region using the marker.

10. The system of claim 9, wherein the controller analyzes the map of baroreceptor regions to identify a location of at least one of the electrodes.